NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous...
Enforcement Report - Week of August 9, 2023
Enforcement Report - Week of May 31, 2023
Enforcement Report - Week of May 24, 2023
ROSEMONT, Ill., May 4, 2023 /PRNewswire/ -- Long Grove Pharmaceuticals announced the strategic in-licensing of Norepinephrine in 0.9% Sodium Chloride premix formulation from Nevakar Injectables, Inc. This manufactured, ready-to-use formulation is room-temperature stable and will be available in three commonly administered strengths; 4mg/250mL (16mcg/mL), 8mg/250mL (32mcg/mL), and 16mg/250mL (64mcg/mL), helping strengthen what has historically been a fragile critical care supply chain.
Enforcement Report - Week of May 11, 2022
Enforcement Report - Week of January 5, 2022
DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX), a global leader in sterile medication production and delivery, today announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of premix Norepinephrine Bitartrate in 5% Dextrose Injection (norepinephrine). Norepinephrine is indicated to raise blood pressure in adult patients with severe, acute hypotension (low blood pressure). Baxter’s formulation of norepinephrine is the first and only manufacturer-prepared ready-to-use formulation and is available in 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL) strengths. Please see Important Risk Information and link to full Prescribing Information below.
Enforcement Report - Week of August 25, 2021
BERLIN, Conn., Aug. 20, 2021 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that it has launched Norepinephrine Bitartrate Injection, USP (generic for Levophed®), manufactured by Rafarm S.A. Breckenridge will market the product in its own label and offer 4 mg/4 mL (1 mg /mL) strength in cartons of 10 vials. According to industry sales data, Levophed and its generics had annual sales of $65 million during the twelve months ending June 2021. The U.S. Food and Drug Administration previously granted final approval of this product's Abbreviated New Drug Application.